IRB FAQs – Continuing Review and Study Closure

How often does the IRB perform a continuing review of an ongoing study?

Federal regulations make no distinction between the issues the IRB must consider during initial review and those they must consider at the time of continuing review. The criteria for initial approval and continuing approval are exactly the same. However, at the time of continuing review, the IRB must also consider whether there has been identified any changes to the risk/benefit ratio. For research that is considered greater than minimal risk and for FDA-regulated research, continuing review will be conducted at intervals appropriate to the degree of risk, no less than once a year.

The length of time between continuing reviews is dependent upon many factors such as whether this research is novel in humans, whether it involves an extremely risky procedure, and the experience of the research team in conducting the procedure, among other factors. It is important that the researcher remains cognizant of the expiration date for their IRB approval and submit a continuing review report which allows sufficient time for the IRB review to occur and the primary investigator to address any concerns the IRB may raise. Continuing review of a study is submitted via the electronic IRB system.

There are exceptions to the requirement for continuing review. Unless the IRB determines otherwise, continuing review of non-FDA-regulated research is not required in the following circumstances:

  • In general, research eligible for expedited review after Jan. 21, 2019 of the 2018 Common Rule changes does not require continuing review;
  • Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
    • Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
    • Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

The IRB reserves the right to require continuing review for other research for which it provides review, approval and oversight.

What should investigators do if IRB approval expires?

If IRB approval of a specific study expires before continuing review and approval occur, investigators must stop all research activities related to that study (45 CFR 46.103(a)), except where they judge that it is in the best interests of those already enrolled to continue to participate. When investigators make this judgment, they must promptly notify the IRB. When the IRB reviews the investigator’s decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects. Investigators may resume the human participant research activity once continuing review and approval by the IRB has occurred.

Do I need to let the IRB know that I have completed a study?

Yes, it is the investigator’s responsibility to notify the IRB that the research study has been completed or terminated for some reason and is being closed. For non-exempt studies that received full or expedited IRB review and approval the study closure should be reported to the IRB via the electronic submission system using the “create final report” function. For studies that were certified exempt study closure should be noted by clicking the button titled “study completed” located on the left side of the screen of the study work space.

What records should investigators keep and for how long?

Researchers are required to maintain, for a minimum of three years, all the following:

  • Any submissions to the IRB (captured in electronic submission system);
  • All correspondence to and from the IRB (which should also be in the electronic submission system); and
  • All signed informed consent documents.

If the research involves the generation, collection or use of protected health information about the participants, the researchers must also maintain the HIPAA authorizations (or documentation of waivers or alterations) and research data for a minimum of six years after the end date of the study.